Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial

NCT ID: NCT01593228

Last Updated: 2017-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-09-30

Brief Summary

The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.

Detailed Description

The Treatment Extension protocol consists of three time points/periods: the Screening Period (during which assessments are performed to determine whether the patient meets the criteria to participate in the study), the Treatment Period (during which the patient receives treatment with the study drug(s)), and the Post-Treatment Period (during which patients complete an evaluation approximately 30 days after the last dose of study drug). Patients may continue to participate on the Treatment Extension study as long as they meet criteria to continue to receive therapy, tolerate the treatment regimen, do not develop progressive disease (PD), do not discontinue from iniparib, do not withdraw consent, or until iniparib becomes commercially available.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:

• Drug: Iniparib monotherapy
• Drug: Iniparib + gemcitabine + carboplatin
• Drug: Iniparib + topotecan
• Drug: Iniparib + irinotecan
• Drug: Iniparib + paclitaxel
• Drug: Iniparib + liposomal doxorubicin + carboplatin

Group Type: EXPERIMENTAL

Iniparib (SAR240550/BSI-201)

Intervention Type: DRUG

Pharmaceutical form:Solution

Route of administration: Intravenous

Carboplatin

Intervention Type: DRUG

Pharmaceutical form:Solution

Route of administration: Intravenous

Doxorubicin HCL liposome injection

Intervention Type: DRUG

Pharmaceutical form:Solution

Route of administration: Intravenous

Gemcitabine

Intervention Type: DRUG

Pharmaceutical form:Solution

Route of administration: Intravenous

Irinotecan

Intervention Type: DRUG

Pharmaceutical form:Solution

Route of administration: Intravenous

Paclitaxel

Intervention Type: DRUG

Pharmaceutical form:Solution

Route of administration: Intravenous

Topotecan

Intervention Type: DRUG

Pharmaceutical form:Solution

Route of administration: Intravenous

Interventions

Iniparib (SAR240550/BSI-201)

Pharmaceutical form:Solution

Route of administration: Intravenous

Intervention Type: DRUG

Carboplatin

Pharmaceutical form:Solution

Route of administration: Intravenous

Intervention Type: DRUG

Doxorubicin HCL liposome injection

Pharmaceutical form:Solution

Route of administration: Intravenous

Intervention Type: DRUG

Gemcitabine

Pharmaceutical form:Solution

Route of administration: Intravenous

Intervention Type: DRUG

Irinotecan

Pharmaceutical form:Solution

Route of administration: Intravenous

Intervention Type: DRUG

Paclitaxel

Pharmaceutical form:Solution

Route of administration: Intravenous

Intervention Type: DRUG

Topotecan

Pharmaceutical form:Solution

Route of administration: Intravenous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen.
• Previously received and are continuing to derive clinical benefit from iniparib, as monotherapy or in combination with chemotherapy, as determined by the treating physician.
• Ongoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol.
• On a stable parental study regimen (at least one cycle for the regimen at the dose/schedule that is to be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). Signed written informed consent.

Exclusion Criteria

• Patient has not previously participated in any clinical trial of iniparib.
• Patient has evidence of progressive disease while receiving iniparib.
• Patient has another concurrent invasive malignancy (aside from the malignancy for which the patient has received therapy for on the parental protocol).
• Patient has a major medical or co-morbid condition(s) that the investigator believes might compromise safe participation in the study (such as uncontrolled lung, kidney, or liver problems; uncontrolled infection; a history of congestive heart failure; or an electrocardiogram suggesting significant problems with the heart).
• Patient has not recovered to baseline or less than Grade 1 from non-hematologic adverse events related to any anticancer therapy received prior to signing informed consent on the Treatment Extension study, with the exception of hair loss.
• Patient is receiving concurrent treatment with other investigational agents not allowed as part of the combination regimen in the parental study protocol.
• Concurrent anticancer treatment with any agent other than iniparib and any co-administered chemotherapeutic agent(s) specified on the parental study protocol are not permitted throughout the course of the study.
• Patient is receiving concurrent radiation therapy to treat primary disease with curative intent. (Note that palliative radiotherapy is allowed as long as there is no evidence of progressive disease.)
• Patient is unable to comply with the requirements of the study.
• Pregnant or breast-feeding women.
• Women of childbearing potential or men with partners of childbearing potential who are not protected or who are unwilling to use an effective contraceptive method of birth control during the course of the study and for a period of 6 months following the last dose.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840013

Birmingham, Alabama, United States

Investigational Site Number 840033

Santa Maria, California, United States

Investigational Site Number 840046

Vallejo, California, United States

Investigational Site Number 840008

Denver, Colorado, United States

Investigational Site Number 840027

Jacksonville, Florida, United States

Investigational Site Number 840063

Augusta, Georgia, United States

Investigational Site Number 840055

Tucker, Georgia, United States

Investigational Site Number 840039

Maywood, Illinois, United States

Investigational Site Number 840012

Indianapolis, Indiana, United States

Investigational Site Number 840025

Sioux City, Iowa, United States

Investigational Site Number 840030

Boston, Massachusetts, United States

Investigational Site Number 840001

Detroit, Michigan, United States

Investigational Site Number 840006

Minneapolis, Minnesota, United States

Investigational Site Number 840002

Jackson, Mississippi, United States

Investigational Site Number 840059

St Louis, Missouri, United States

Investigational Site Number 840004

St Louis, Missouri, United States

Investigational Site Number 840022

Las Vegas, Nevada, United States

Investigational Site Number 840017

Voorhees Township, New Jersey, United States

Investigational Site Number 840010

Albany, New York, United States

Investigational Site Number 840015

Charlotte, North Carolina, United States

Investigational Site Number 840060

Cincinnati, Ohio, United States

Investigational Site Number 840043

Cleveland, Ohio, United States

Investigational Site Number 840021

Pittsburgh, Pennsylvania, United States

Investigational Site Number 840028

Memphis, Tennessee, United States

Investigational Site Number 840007

Austin, Texas, United States

Investigational Site Number 840003

El Paso, Texas, United States

Investigational Site Number 840019

Plano, Texas, United States

Investigational Site Number 840005

Norfolk, Virginia, United States

Investigational Site Number 840009

Vancouver, Washington, United States

Investigational Site Number 056002

Leuven, , Belgium

Investigational Site Number 380002

Genova, , Italy

Investigational Site Number 724001

Valencia, , Spain

Countries

United States; Belgium; Italy; Spain

Other Identifiers

2011-006246-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1127-0888

Identifier Type: OTHER

Identifier Source: secondary_id

LTS12674

Identifier Type: -

Identifier Source: org_study_id